Efficacy and Safety Study of Isuzinaxib in Subjects With DKD
NCT ID: NCT06962098
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
186 participants
INTERVENTIONAL
2025-05-26
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Isuzinaxib 400 mg
Subject will receive the 400 mg of Isuzinaxib.
Isuzinaxib
Oral dosing regimen once daily
Isuzinaxib 200 mg
Subject will receive the 200 mg of Isuzinaxib.
Isuzinaxib
Oral dosing regimen once daily
Placebo
Subject will receive the Placebo.
Placebo
Oral dosing regimen once daily
Interventions
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Isuzinaxib
Oral dosing regimen once daily
Placebo
Oral dosing regimen once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of type 2 diabetes and DKD.
3. 18.5 kg/m² \< body mass index \< 35 kg/m².
4. Stable UACR values prior to screening visit.
5. UACR between 200 and 3000 mg/g.
6. Hemoglobin A1c ≤10% at Screening Visit.
7. Subject who has been taking unchanged dosage of angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blockers (ARB) medication.
8. Subject who has been on stable anti-hyperglycemic prior to screening.
9. Females of childbearing potential/sexually active males with a partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control.
10. Willing to be under dietary management for diabetes.
11. Willing to comply with all study procedures and availability for the duration of the study.
12. Capable of understanding the content of and able voluntarily to provide a signed and dated written informed consent form (ICF) prior to any study procedures.
Exclusion Criteria
2. Subject's renal impairment and/or albuminuria is considered to be of origin other than DKD.
3. History of renal transplant and/or plan to undergo a renal transplant during the study.
4. History of acute kidney injury or renal dialysis.
5. Subject with uncontrolled blood pressure.
6. Subject taking immunosuppressant.
7. Subject with known or suspected hypersensitivity to any components of the APX-115 formulation.
8. Clinically significant abnormal laboratory findings at screening.
9. History of drug or alcohol abuse within 1 year prior to screening.
10. History of any cardiovascular event or cardiovascular procedure planned during the clinical study.
11. Current or history of New York Heart Association class III or IV heart failure.
12. Clinically significant electrocardiogram (ECG) abnormalities.
13. Known significant liver disease.
14. Subject with active urinary tract infection or has not fully recovered before randomization.
15. History of malignancy within 5 years prior to screening.
16. Administration of any investigational product.
17. Major surgery within 28 days or not fully recovered surgery prior to randomization or major surgery planned during the next 6 months.
18. Positive hepatitis B surface antigen.
19. Female subject who is pregnant or breastfeeding.
20. Other medical history which in the opinion of the Investigator would make the subject unsuitable for participation in the study.
21. Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study or unable to cooperate because of a language problem or poor mental status.
19 Years
ALL
No
Sponsors
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Aptabio Therapeutics, Inc.
INDIV
Responsible Party
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Locations
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Korea University Ansan Hospital
Ansan-si, , South Korea
Inje university Busan Paik Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
SoonChunHyang University Hospital Cheonan
Cheonan, , South Korea
Keimyung University Daegu Dongsan Hospital
Daegu, , South Korea
Inje university Ilsan Paik Hospital
Goyang-si, , South Korea
Hanyang University Guri Hospital
Guri-si, , South Korea
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, , South Korea
The Catholic University of Korea Incheon St. Mary's Hospital
Incheon, , South Korea
Jeonbuk National University Hospital
Jeonju, , South Korea
CHA Bundang Medical Center
Seongnam-si, , South Korea
Boramae Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Kyung Hee University Hospital at Gangdon
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
The Catholic University of Korea Seoul ST.MARY'S Hospital
Seoul, , South Korea
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si, , South Korea
Wonju Severance Christian Hospital
Wŏnju, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Jin-Joo Cha
Role: primary
Taehee Kim
Role: primary
Sang Heon Song
Role: primary
EunYoung Lee
Role: primary
Seung-Yeup Han
Role: primary
Sang Youb Han
Role: primary
Sang-Woong Han
Role: primary
Su-Hyun Kim
Role: primary
Seok Joon Shin
Role: primary
Won Kim
Role: primary
So-Young Lee
Role: primary
Jung-Pyo Lee
Role: primary
Gang-jee Ko
Role: primary
Ju-Young Moon
Role: primary
Seung Seok Han
Role: primary
Tae-Hyun Yoo
Role: primary
Yaeni Kim
Role: primary
Sun-Ae Yoon
Role: primary
Byoung Geun Han
Role: primary
Seo Rin Kim
Role: primary
Other Identifiers
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APX-115-05
Identifier Type: -
Identifier Source: org_study_id
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